FDA Adverse Event
Summary report: N
MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT
MDR report key: 3952127
·
Received July 23, 2014
Report
- Report Number
- 1531186-2014-02694
- Date Received
- July 23, 2014
- Report Date
- June 11, 2014
- Manufacturer
- C.T.M. TAIWAN
- Product Code
- INI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THE COMET4-B SCOOTER KEEPS SPEEDING UP AND SLOWING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431484 | MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT | 890.3800 | INI | C.T.M. TAIWAN | COMET4-B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |